> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Bench Performance Test Report Guidance
- URL: https://www.fdaweb.com/bench-performance-test-report-guidance/
- Published: 2018-05-30T12:00:00.000Z
- Updated: 2026-09-15T00:09:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141560

FDA has published a draft guidance, *Recommended Content and Format of Test Reports for Complete Non-Clinical Bench Performance Testing in Premarket Submissions*, to describe relevant information that the agency wants included in complete test reports for non-clinical bench performance testing provided in a pre-market submission (PMA, HDE, 510(k), IDE, and de novo). For purposes of the [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM606051.pdf?ref=fdaweb.com), bench performance testing is defined as performance testing that encompasses all bench testing and will be dependent on the specifics of the actual device or device type. Non-clinical bench performance testing includes, but is not limited to, mechanical and biological engineering performance (such as fatigue, wear, tensile strength, compression, burst pressure); bench tests using animal or human tissue; and animal carcass or human cadaveric testing.